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Windstone Medical Packaging, Inc.
Windstone Medical Packaging, Inc.: 324 FDA recall reports
Every medical device recall the FDA has published for Windstone Medical Packaging, Inc.. The fault, and how the agency graded it.
324Reports
10Class I
24Ongoing
2026-07-08Most recent
10 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.
Class I
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Z-2622-2026 · Class I · reported 2026-07-08 · Ongoing
- Why it was recalled
- Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
- Where it went
- US Nationwide distribution in the states of PA, GA, CA, WA.
- How much
- 45 units
Class I
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Z-2620-2026 · Class I · reported 2026-07-08 · Ongoing
- Why it was recalled
- Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- Where it went
- US Nationwide distribution in the states of PA, GA, CA, WA.
- How much
- 200 units
Class I
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Z-2619-2026 · Class I · reported 2026-07-08 · Ongoing
- Why it was recalled
- Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- Where it went
- US Nationwide distribution in the states of PA, GA, CA, WA.
- How much
- 1080 kits
Class I
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Z-2621-2026 · Class I · reported 2026-07-08 · Ongoing
- Why it was recalled
- Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- Product
- A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
- Where it went
- US Nationwide distribution in the states of PA, GA, CA, WA.
- How much
- 200 units
Aligned Medical AMS16835 Fluids Kit RX
Z-2307-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
- Product
- Aligned Medical AMS16835 Fluids Kit RX
- Where it went
- US Nationwide distribution in the states of IL, VA.
- How much
- 875 kits
Class I
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (
Z-2066-2026 · Class I · reported 2026-05-20 · Ongoing
- Why it was recalled
- Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
- Product
- Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
- Where it went
- US Nationwide distribution in the state of Arizona.
- How much
- 150 kits (US only)
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Z-1920-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Where it went
- US Nationwide distribution in the states of GA, OR, TN, and WA.
- How much
- 380 units
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Z-1921-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
- Where it went
- US Nationwide distribution in the states of GA, OR, TN, and WA.
- How much
- 520 units
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Z-1919-2026 · Class II · reported 2026-04-29 · Ongoing
- Why it was recalled
- The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- Product
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
- Where it went
- US Nationwide distribution in the states of GA, OR, TN, and WA.
- How much
- 475 units
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product pac
Z-0029-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Product
- Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Where it went
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- How much
- 60 packs
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product p
Z-0030-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Product
- Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Where it went
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- How much
- 40 packs
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product pa
Z-0027-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Product
- Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Where it went
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- How much
- 642 kits
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product pa
Z-0031-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Product
- Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Where it went
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- How much
- 180 packs
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product
Z-0028-2025 · Class II · reported 2024-10-16 · Ongoing
- Why it was recalled
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Product
- Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Where it went
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- How much
- 894 kits
Class I
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Z-1081-2024 · Class I · reported 2024-02-28 · Ongoing
- Why it was recalled
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
- Where it went
- US: FL, IL, CA OUS: None
- How much
- 80 kits
Class I
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Z-1080-2024 · Class I · reported 2024-02-28 · Ongoing
- Why it was recalled
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Product
- Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
- Where it went
- US: FL, IL, CA OUS: None
- How much
- 128 kits
Class I
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Z-1082-2024 · Class I · reported 2024-02-28 · Ongoing
- Why it was recalled
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Product
- Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Where it went
- US: FL, IL, CA OUS: None
- How much
- 475 kits
Class I
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Z-1079-2024 · Class I · reported 2024-02-28 · Ongoing
- Why it was recalled
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Product
- Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
- Where it went
- US: FL, IL, CA OUS: None
- How much
- 1,528 units
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Z-1621-2023 · Class II · reported 2023-05-31 · Ongoing
- Why it was recalled
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Product
- Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Where it went
- US: MA OUS: None
- How much
- 60 kits
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Steril
Z-1620-2023 · Class II · reported 2023-05-31 · Ongoing
- Why it was recalled
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Product
- Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Where it went
- US: MA OUS: None
- How much
- 90 kits
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Z-1619-2023 · Class II · reported 2023-05-31 · Ongoing
- Why it was recalled
- Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
- Product
- Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Where it went
- US: MA OUS: None
- How much
- 30 kits
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasi
Z-0881-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
- Product
- Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack ...
- Where it went
- Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.
- How much
- 9,489 kits
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits w
Z-1101-2022 · Class II · reported 2022-05-25 · Ongoing
- Why it was recalled
- Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.
- Product
- Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast...
- Where it went
- US: PA, WA, FL, GA
- How much
- 53,412
Class I
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned
Z-0119-2022 · Class I · reported 2021-11-10 · Ongoing
- Why it was recalled
- Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.
- Product
- Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack
- Where it went
- FL and PA
- How much
- 9,378
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel
Z-1848-2021 · Class II · reported 2021-06-23 · Terminated
- Why it was recalled
- Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
- Product
- Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike Bag decanter 6 Syringe 10cc L/L 10 Towel or Blue 2 Bag Band 36 X 50 W/TP 1 Prep Ultra Sound Gel Packet 1 Bowl Denture Cup 8 oz (250C 1 Bowl 32 oz (1000CC) 1 Cover Set UP 54X90 1 Instr Forcep Kelly Strt 5.5 1 Angio Tubing HP 10 W/ROT M/L 1 Needle Introducer 21G 1 Dressing Telfa 3X4 2 Syringe 20cC L/L 1 Guidewire Nitinol .018X45CM 1 Drape Angio 80 X 125 W/2 WIN 1 Introducer 5F X 10CM Stiff.
- Where it went
- US Nationwide distribution in the state of AZ.
- How much
- 114 units
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI
Z-1849-2021 · Class II · reported 2021-06-23 · Terminated
- Why it was recalled
- Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
- Product
- Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz (250C 4 Clamp Towel 2.5 1 Drape Angio/FEM 87X124 W/2 V 1 Angio Tubing HP 10 W/ROT M/L 1 Needle RB 22 X 1.5 30 Sponge 4 X 4 X 12 Plain 10 Towel or Blue 1 Prep Ultrasound Gel Packet 1 Bowl Guidewire 80 Oz (2500C 1 Cover Backtable 50 X 90 Zoni 1 Instr Forcep Kelly Strt 5.5 10 Label Custom 1 Counter Needle Nest 6 Syringe 10CC L/L 1 Bag Band Dome 22 2 Prep Chloraprep One-Step 3
- Where it went
- US Nationwide distribution in the state of AZ.
- How much
- 190 units
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Z-0069-2018 · Class II · reported 2017-11-15 · Terminated
- Why it was recalled
- Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
- Product
- AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Where it went
- US Distribution to the state of : SC
- How much
- 60 kits
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged i
Z-1785-2017 · Class II · reported 2017-04-19 · Terminated
- Why it was recalled
- AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Product
- Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure
- Where it went
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- How much
- 7,508 kits
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clini
Z-1787-2017 · Class II · reported 2017-04-19 · Terminated
- Why it was recalled
- AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Product
- Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
- Where it went
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- How much
- 172 kits
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedu
Z-1797-2017 · Class II · reported 2017-04-19 · Terminated
- Why it was recalled
- AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Product
- PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
- Where it went
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- How much
- 20 kits
Showing the 30 most recent of 324. 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.
← All device recalls