Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
CriticalFDA
Carefusion 213, Llc
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 app...
Drugs·2,800,800 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Appl...
Drugs·12,500 affected·Jun 23, 2020
CriticalFDA
Carefusion 213, Llc
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Pa...
Drugs·4,272,300 affected·Jun 23, 2020
High RiskFDA
Argon Medical Devices, Inc
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are...
Surgical Devices·1,000 affected·Jun 19, 2020
High RiskFDA
Resource Optimization & Innovation Llc
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed ...
Medical Devices·66 affected·Jun 17, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Surgical Devices·39,800 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 ...
Surgical Devices·180 affected·May 27, 2020
High RiskFDA
Prodimed Plastimed Division
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Surgical Devices·7,220 affected·May 27, 2020
High RiskFDA
Tedan Surgical Innovations Llc
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervic...
Medical Devices·2,735 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·730 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the...
Medical Devices·1,965 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior app...
Medical Devices·340 affected·May 15, 2020
High RiskFDA
Tedan Surgical Innovations Llc
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior appr...
Medical Devices·495 affected·May 15, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin 50mg/mL, 10 mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Curcumin, 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Biota Biosciences Llc
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Drugs·0 affected·May 11, 2020
High RiskFDA
Stryker Gmbh
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intende...
Medical Implants·26 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use dev...
Medical Implants·76 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use dev...
Medical Implants·40 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the te...
Medical Implants·186 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the tem...
Medical Implants·3 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devic...
Medical Implants·400 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use d...
Medical Implants·3 affected·May 7, 2020
High RiskFDA
Stryker Gmbh
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices inten...
Medical Implants·69 affected·May 7, 2020
High RiskFDA
Biomet
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Surgical Devices·705 affected·May 1, 2020
High RiskFDA
Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Surgical Devices·136 affected·May 1, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter P...
Surgical Devices·46,828 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Lu...
Surgical Devices·3,470 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with L...
Surgical Devices·23,587 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 ...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Thermo Fisher Scientific (monterrey)
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used fo...
Medical Devices·78,600 affected·Apr 29, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Medical Devices·325 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Medical Devices·768 affected·Apr 24, 2020
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack ...
Cardiac Devices·352 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Medical Devices·48 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Medical Devices·72 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Medical Devices·984 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Medical Devices·24 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Medical Devices·420 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Medical Devices·860 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Medical Devices·600 affected·Apr 24, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: ...
Medical Devices·110 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is...
Medical Devices·120 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: i...
Medical Devices·6,254 affected·Apr 23, 2020