FDA (Devices) recall action 95946

Sklar Instruments recalled 30 products on 2025-01-22

The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.

Products: 30
Announced: 2025-01-22
Critical: 0
Units: 554,075

Why these products were recalled

Reports of various packaging issues that may result in a breach of the sterile barrier.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 30

HighFDA (Devices)··2025-01-22
Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues
Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.
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
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HighFDA (Devices)··2025-01-22
Sklar Instruments iris hooks recalled for sterile packaging integrity issues
Sklar Instruments is recalling ECONO STERILE iris hook surgical kits due to packaging defects that may compromise sterile barrier integrity. No injuries reported.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
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0 states
HighFDA (Devices)··2025-01-22
ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk
Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
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0 states
HighFDA (Devices)··2025-01-22
Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
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0 states
HighFDA (Devices)··2025-01-22
Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.
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 ST
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HighFDA (Devices)··2025-01-22
ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues
Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach 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
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0 states
HighFDA (Devices)··2025-01-22
ECONO STERILE medical procedure kits recalled for potential sterile barrier breach
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
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
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ModerateFDA (Devices)··2025-01-22
Sklar Instruments ECONO STERILE Blackhead Extractor Kits Recall
Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
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0 states
HighFDA (Devices)··2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
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
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HighFDA (Devices)··2025-01-22
Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.
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 PEDER
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HighFDA (Devices)··2025-01-22
Sklar Instruments Recalls ECONO STERILE Surgical Scalpel Handles for Sterile Barrier Risk
Sklar Instruments recalls ECONO STERILE SCALPEL HDL #3 surgical handles due to packaging issues that may compromise the sterile barrier. The 150-unit recall affects units distributed nationwide with lot code SK-125.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
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0 states
HighFDA (Devices)··2025-01-22
Medical procedure kit recall due to sterile barrier packaging breach risk
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
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
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0 states
HighFDA (Devices)··2025-01-22
Sklar Instruments Recalls ECONO STERILE Medical Procedure Kits for Sterile Barrier Breach Risk
Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.
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 FRCP
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HighFDA (Devices)··2025-01-22
Sklar Instruments Recalls Sterile Vein Hooks Due to Packaging Issues
Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.
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 proced
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HighFDA (Devices)··2025-01-22
ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
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0 states
HighFDA (Devices)··2025-01-22
Strabismus Surgical Scissors Kits Recalled Due to Sterile Barrier Packaging Issues
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise 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 STRABISM
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HighFDA (Devices)··2025-01-22
Surgical Suction Tubes Recalled for Sterile Packaging Defects
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.
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
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HighFDA (Devices)··2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
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)
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HighFDA (Devices)··2025-01-22
ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
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
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HighFDA (Devices)··2025-01-22
Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.
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;
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HighFDA (Devices)··2025-01-22
ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.
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 STER
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HighFDA (Devices)··2025-01-22
ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
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
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HighFDA (Devices)··2025-01-22
Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
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0 states
HighFDA (Devices)··2025-01-22
Gynecological dilator kits recalled for potential sterile barrier compromise
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
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
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HighFDA (Devices)··2025-01-22
Medical Procedure Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
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