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 the agency’s own highest classification or reported deaths or serious injuries, 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

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

35101–35125 of 40449

SevereFDA (Devices)·Z-2474-2014·2014-09-10
Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 612 units of Urology Pack 900-2510 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SPONGE 4" X 4" 12PL Y (1) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) TUR Y SET 81 " 2.1M REGULAR CLAM (1) GOWN SURG REINFORCED LGE TOWEL &…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2512-2014·2014-09-10
Customed Recalls TLIF Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling TLIF Surgical Center packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS ABSORBEN 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2445-2014·2014-09-10
Customed Recalls Laparoscopic Colorectal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of laparoscopic colorectal surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2330-2014·2014-09-10
Customed Recalls EO Sterilized Laparotomy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 550 units of EO sterilized laparotomy basic packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Product
LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1 0) GAUZE SPONGES XRD 4" X 4"-12PL Y (2) DRAPE SHEET 41 " X 58" SMS UF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2343-2014·2014-09-10
Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 47 lots of EO-sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2434-2014·2014-09-10
Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2454-2014·2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Total Hysterectomy surgical packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Product
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I )…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2424-2014·2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 19 lots of EO-sterilized laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2310-2014·2014-09-10
Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise sterility.
Product
Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2476-2014·2014-09-10
Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.
Product
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2443-2014·2014-09-10
Customed Recalls Neuro Packs Due to Potential Packaging Integrity Compromise
Customed, Inc. is recalling Neuro Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2417-2014·2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2497-2014·2014-09-10
Customed Recalls Debridement Trays Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Debridement Trays (code 900-2702) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2014·2014-09-10
Spacelabs Ariatele Telemetry Transmitter Recalled for SpO2 Display Errors
Spacelabs is recalling Ariatele Telemetry Transmitters because they may display SpO2 values when sensors are disconnected or failed.
Product
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2576-2014·2014-09-10
Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage
Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2014·2014-09-10
Hill-Rom Affinity Four Birthing Bed Recall for Latch Mechanism Defect
Hill-Rom is recalling 13,000 Affinity Four Birthing Beds because the attachment latch mechanism can bend, potentially causing the foot section to fail and resulting in user injury from a fall.
Product
Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2584-2014·2014-09-10
Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion
Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.
Product
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2581-2014·2014-09-10
Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery
Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.
Product
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2578-2014·2014-09-10
Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall
Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2588-2014·2014-09-10
Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk
Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.
Product
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2590-2014·2014-09-10
Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits
Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.
Product
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2589-2014·2014-09-10
Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk
Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.
Product
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2565-2014·2014-09-10
Bio-Detek Recalls Medsolutions4U Multi-Function Electrodes Due to Connector Defect
Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes because an incorrect wire connector prevents them from interfacing with PhysioControl Lifepak Defibrillators.
Product
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2577-2014·2014-09-10
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage
Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2580-2014·2014-09-10
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage
Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.
Product
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
Category
Medical Device
Distribution
Distributed nationwide

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35101–35125 of 40449