Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

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526–550 of 582

CriticalFDA (Devices)·Z-2422-2014·2014-09-10
Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2340-2014·2014-09-10
Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise
Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Product
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2427-2014·2014-09-10
Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY AB
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2453-2014·2014-09-10
Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE SUC
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2346-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2381-2014·2014-09-10
Customed Recalls Premium Ophthalmic Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2481-2014·2014-09-10
Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1539-2014·2014-05-28
Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk
Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.
Product
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1471-2014·2014-04-30
Heartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation
HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The Hear
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1454-2014·2014-04-23
FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1228-2014·2014-04-02
Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.
Product
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1230-2014·2014-04-02
Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.
Product
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1227-2014·2014-04-02
Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries
Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.
Product
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-229-2014·2014-04-02
Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries
Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.
Product
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1212-2014·2014-03-26
Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results
Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.
Product
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0957-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0950-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0956-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0951-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0261-2014·2013-11-27
Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.
Product
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2295-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the fillin
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2298-2013·2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2123-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2125-2013·2013-09-18
Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gra
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2124-2013·2013-09-18
Siemens Microscan Plus Negative Combo 3 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
Category
Medical Device
Distribution
Distributed nationwide

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526–550 of 582