TELEFLEX MEDICAL INC: 32 FDA recall reports
Every medical device recall the FDA has published for TELEFLEX MEDICAL INC. The fault, and how the agency graded it.
32Reports
11Class I
5Ongoing
2022-06-01Most recent
11 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732,
Z-1126-2022 · Class II · reported 2022-06-01 · Ongoing
- Why it was recalled
- Reports received of torn corrugated breathing tubes.
- Product
- (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.
- How much
- 59,581 eaches
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22
Z-1127-2022 · Class II · reported 2022-06-01 · Ongoing
- Why it was recalled
- Reports received of torn corrugated breathing tubes.
- Product
- (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.
- How much
- 290,809 eaches
Class I
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component:
Z-0625-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 1265 units
Class I
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components
Z-0626-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 1874 units
Class I
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing component
Z-0628-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 5530 units
Class I
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Tre
Z-0629-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 14583 units
Class I
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-4
Z-0627-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 3668 units
Class I
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing componen
Z-0624-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 1400 units
Class I
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing component
Z-0623-2022 · Class I · reported 2022-02-23 · Terminated
- Why it was recalled
- The firm received reports indicating PTD tip separation during use.
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
- Where it went
- Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
- How much
- 676 units
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structur
Z-1294-2021 · Class II · reported 2021-03-31 · Ongoing
- Why it was recalled
- Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
- Product
- RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada.
- How much
- 157, 150 units (156,980 units in the US; 170 units OUS)
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, singl
Z-1298-2021 · Class II · reported 2021-03-31 · Terminated
- Why it was recalled
- Teleflex is recalling this product due to a lack of assurance of sterility.
- Product
- PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.
- Where it went
- US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.
- How much
- 520 units (US only)
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any su
Z-2922-2020 · Class II · reported 2020-09-09 · Terminated
- Why it was recalled
- Potential sterility issue
- Product
- Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days.
- Where it went
- US Distribution of states to: AR AZ CA CO FL GA IA IL IN LA MI MN MS NC NH NV NY OH OK OR PA SD TN TX VA WA WI
- How much
- 700 eaches
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuat
Z-2749-2020 · Class II · reported 2020-08-12 · Terminated
- Why it was recalled
- Potential for sterile packaging to be compromised¿
- Product
- Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
- How much
- 1812 each (US)
Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air
Z-2748-2020 · Class II · reported 2020-08-12 · Terminated
- Why it was recalled
- Potential for sterile packaging to be compromised¿
- Product
- Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and maintain normal intra-thoracic pressure gradients. To facilitate complete lung re-expansion to restore normal breathing dynamics.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of FL, PR and the countries of AL, BR, CR, EC, ES, GB, GR, HK, HN, ID, IT, MX, PA, PE, PH, PK, PR, SG, SV, VE.
- How much
- 204644 each (OUS)
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a
Z-2726-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 75320 units
Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a
Z-2731-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 350779 units
Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a
Z-2727-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 27341 units
Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a de
Z-2732-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 29740 units
Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a
Z-2730-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 301085 units
Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a
Z-2729-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 20600 units
Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a
Z-2728-2020 · Class II · reported 2020-08-05 · Terminated
- Why it was recalled
- Breaking at the point of a welded joint
- Product
- Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
- Where it went
- US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.
- How much
- 7401 units
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Prod
Z-2533-2020 · Class II · reported 2020-07-15 · Terminated
- Why it was recalled
- Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
- Product
- RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.
- Where it went
- US Nationwide distribution.
- How much
- 6014 devices
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar punc
Z-2129-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
- Product
- Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.
- Where it went
- Nationwide distribution.
- How much
- 4227 devices
Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar punc
Z-2130-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
- Product
- Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.
- Where it went
- Nationwide distribution.
- How much
- 800 devices
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Z-1269-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- Product
- Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
- Where it went
- Worldwide
- How much
- 1764 units
Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36
Z-1270-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
- Product
- Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K
- Where it went
- Worldwide
- How much
- 587066 units
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Z-1117-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
- Product
- Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
- Where it went
- Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
- How much
- 338,928 (199,018 US and 139,910 OUS) for all products
Class I
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
Z-1114-2020 · Class I · reported 2020-02-19 · Terminated
- Why it was recalled
- There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
- Product
- HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
- Where it went
- nationwide
- How much
- 127293 devices
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Z-1116-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
- Product
- Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
- Where it went
- Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
- How much
- 338,928 (199,018 US and 139,910 OUS) for all products
Class I
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Z-1112-2020 · Class I · reported 2020-02-19 · Terminated
- Why it was recalled
- There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
- Product
- HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
- Where it went
- nationwide
- How much
- 30566 devices
Showing the 30 most recent of 32. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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