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

31501–31525 of 40325

HighFDA (Devices)·Z-0286-2016·2015-11-25
Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
Product
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2016·2015-11-25
Civco Biopsy Starter Kit Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.
Product
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0297-2016·2015-11-25
Roche Bulk Loader Module Recalled for Sample Contamination Risk
Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.
Product
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0293-2016·2015-11-25
TZ Medical Neptune Plus Hemostasis Pad Recall for Labeling Mismatch
TZ Medical Inc. is recalling Neptune Plus hemostasis pads because the instructions for use do not match the original FDA submission.
Product
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0275-2016·2015-11-25
Medacta Recalls GMK Hinge Knee Prosthesis Due to Incorrect Screws
Medacta USA is recalling 4 units of GMK Hinge knee prostheses because they contain 5 mm screws instead of the required 10 mm screws.
Product
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0312-2016·2015-11-25
Ameditech Recalls Immutest Drug Screen Cups Due to Reduced Reactivity
Ameditech is recalling specific Immutest drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and in Australia.
Product
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0298-2016·2015-11-25
Ameditech Recalls 1 Step 12 Panel Cup Drug Tests
Ameditech is recalling 787 kits of 1 Step 12 Panel Cup drug tests due to reduced reactivity. The products were distributed in the US and Australia.
Product
1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0279-2016·2015-11-25
Astora Recalls MiniArc Pro Sling System Due to Labeling Mismatch
Astora is recalling 52 units of the MiniArc Pro Single incision Sling System because the lot number on the outer carton did not match the labels inside the box.
Product
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0311-2016·2015-11-25
Ameditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity
Ameditech is recalling iCup drug screen cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Product
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0278-2016·2015-11-25
Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect
Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.
Product
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0300-2016·2015-11-25
Ameditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity
Ameditech is recalling 11 Panel Drug Abuse Tests because they have shown reduced reactivity. The affected products are distributed in the US and Australia.
Product
11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0318-2016·2015-11-25
TZ Medical Recalls SilverStat Hemostasis Pads Due to Labeling Discrepancy
TZ Medical Inc. is recalling 10,180 units of SilverStat hemostasis pads because the instructions for use did not match the original FDA submission.
Product
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure…
Category
Medical Device
Distribution
18 states
ModerateFDA (Devices)·Z-0303-2016·2015-11-25
Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Reduced Reactivity
Ameditech is recalling ArcPoint Labs 10 Panel Dip Screen (OXY) drug tests because they have shown reduced reactivity.
Product
ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0315-2016·2015-11-25
Ameditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity
Ameditech is recalling ProScreen drug panel tests because they have shown reduced reactivity. The recall covers 31,530 units distributed in the US and Australia.
Product
ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0304-2016·2015-11-25
Ameditech Recalls CLIA RDTC 12-Panel Drug Abuse Tests for Reduced Reactivity
Ameditech is recalling 7,482 units of CLIA RDTC 12-Panel Cup drug abuse tests because they have shown reduced reactivity. The products were distributed in the US and Australia.
Product
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0317-2016·2015-11-25
Ameditech Recalls Thermo Fisher 6 Drug Cassettes Due to Reduced Reactivity
Ameditech is recalling Thermo Fisher 6 Drug Cassettes because they have shown reduced reactivity. The recall affects 220 units distributed in the US and Australia.
Product
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0283-2016·2015-11-25
Agfa Healthcare Recalls IMPAX CV Software for Incorrect PDF Reports
Agfa Healthcare is recalling IMPAX CV software versions 7.8.x and 12.x because the Demographics Manager feature may generate incorrect PDF reports after physician signature.
Product
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0309-2016·2015-11-25
Ameditech Recalls DrugSmart Dip Drug Abuse Tests Due to Reduced Reactivity
Ameditech is recalling 160 units of DrugSmart Dip drug abuse tests because they have shown reduced reactivity. The affected products were distributed in the US and Australia.
Product
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D; DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0308-2016·2015-11-25
Ameditech Recalls DrugSmart Drug Abuse Test Cups Due to Reduced Reactivity
Ameditech is recalling specific DrugSmart drug abuse test cups because they have shown reduced reactivity. The affected units were distributed in the US and Australia.
Product
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 60960D; DrugSmart Cup 10, Item No. 61093D-3C These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2016·2015-11-25
Ameditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests
Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.
Product
Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0316-2016·2015-11-25
Ameditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity
Ameditech is recalling 2,240 units of 6 Panel Cup Body and Lid drug tests because they have shown reduced reactivity.
Product
The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0307-2016·2015-11-25
Ameditech Recalls DrugSmart 10 Test Cups Due to Reduced Reactivity
Ameditech is recalling DrugSmart 10 Test Cups because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Product
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2016·2015-11-25
Ameditech Recalls 10-Panel Pipette Drug Screen Due to Reduced Reactivity
Ameditech is recalling 10-Panel Pipette Drug Screen tests because they have shown reduced reactivity. The recall affects 200 units distributed in the US and Australia.
Product
10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0305-2016·2015-11-25
Ameditech Recalls DrugCheck Pipette 10 Drug Tests Due to Reduced Reactivity
Ameditech is recalling 70 units of DrugCheck Pipette 10 Drug Tests because they have shown reduced reactivity. The affected tests were distributed in the US and Australia.
Product
DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0302-2016·2015-11-25
Ameditech Recalls 12-Panel Dip Drug Screens Due to Reduced Reactivity
Ameditech is recalling 12-Panel Dip Drug Screens with adulterant because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Product
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
Category
Medical Device
Distribution
Distributed nationwide

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