thejoe Sklar Instruments

Sklar Instruments: 30 FDA recall reports

Every medical device recall the FDA has published for Sklar Instruments. The fault, and how the agency graded it.

30Reports

0Class I

30Ongoing

2025-01-22Most recent

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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	30

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.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Numbe

Z-0946-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators
Where it went: Domestic: Nationwide Distribution
How much: 75 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Num

Z-0936-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
Where it went: Domestic: Nationwide Distribution
How much: 300 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number

Z-0931-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 9

Z-0939-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; ...
Where it went: Domestic: Nationwide Distribution
How much: 245015 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Num

Z-0943-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-01

Z-0927-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Numb

Z-0930-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures
Where it went: Domestic: Nationwide Distribution
How much: 175 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number

Z-0949-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Where it went: Domestic: Nationwide Distribution
How much: units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Num

Z-0938-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices
Where it went: Domestic: Nationwide Distribution
How much: 150 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Num

Z-0954-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE...
Where it went: Domestic: Nationwide Distribution
How much: 41850 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number

Z-0945-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Where it went: Domestic: Nationwide Distribution
How much: 40 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Num

Z-0929-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor
Where it went: Domestic: Nationwide Distribution
How much: 75 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923;

Z-0953-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Where it went: Domestic: Nationwide Distribution
How much: 2500 units

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Mode

Z-0926-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Where it went: Domestic: Nationwide Distribution
How much: 125 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number

Z-0952-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Num

Z-0933-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
Where it went: Domestic: Nationwide Distribution
How much: 1050 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number

Z-0944-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological
Where it went: Domestic: Nationwide Distribution
How much: 475 units

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540;

Z-0950-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
Where it went: Domestic: Nationwide Distribution
How much: 350 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number

Z-0937-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Where it went: Domestic: Nationwide Distribution
How much: 150 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Num

Z-0932-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
Where it went: Domestic: Nationwide Distribution
How much: 7730 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Numb

Z-0935-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures
Where it went: Domestic: Nationwide Distribution
How much: 1050 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Number

Z-0928-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Mo

Z-0925-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Where it went: Domestic: Nationwide Distribution
How much: 25 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number

Z-0942-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Where it went: Domestic: Nationwide Distribution
How much: 25 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number

Z-0951-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Where it went: Domestic: Nationwide Distribution
How much: 25 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number

Z-0940-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Numbe

Z-0941-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; ...
Where it went: Domestic: Nationwide Distribution
How much: 252865 units

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Num

Z-0947-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
Where it went: Domestic: Nationwide Distribution
How much: 0 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number

Z-0934-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Where it went: Domestic: Nationwide Distribution
How much: 25 units

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number

Z-0948-2025 · Class II · reported 2025-01-22 · Ongoing

Why it was recalled: Reports of various packaging issues that may result in a breach of the sterile barrier.
Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Where it went: Domestic: Nationwide Distribution
How much: 0 units

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